FDA PMA and HDE Submission Changes Under QMSR: Draft Guidance

FDA changes to PMA and HDE submission content under the QMSR: what the October 2025 draft guidance does

Bottom line

There is one formal, on-point FDA change: a draft guidance issued October 27, 2025, "Quality Management System Information for Certain Premarket Submission Reviews" ²¹²⁶. It updates how QMS information should be presented in PMA and HDE submissions so that, once the QMSR takes effect, FDA can assess whether the submission's documents and records conform to the amended Part 820 ¹²⁶¹²⁷. When finalized, it will supersede the long-standing 2003 guidance "Quality System Information for Certain Premarket Application Reviews" ¹⁴⁵.

Access the draft here: https://www.fda.gov/media/189345/download ²

Regulatory background: what the QMSR is

The QMSR is the revised 21 CFR Part 820. FDA created it through the final rule "Medical Devices; Quality System Regulation Amendments," published February 2, 2024 at 89 FR 7496, with a delayed effective date of February 2, 2026 ¹³⁸¹³⁹. The rule withdraws most of the current Part 820 text and instead incorporates by reference ISO 13485:2016 (and Clause 3 of ISO 9000:2015 for definitions) ¹³⁰¹³⁸¹³⁹. FDA's position is that ISO 13485 requirements, taken in totality, are substantially similar to the prior Quality System regulation and provide a comparable level of assurance for safe, effective, and compliant manufacturing ¹³⁰¹³⁹¹⁴¹¹⁴²¹⁴³.

Because the underlying regulation changed, the guidance describing what QMS information belongs in a marketing submission had to be refreshed. That is the purpose of the October 2025 draft.

The formal change: October 2025 draft guidance

Title: Quality Management System Information for Certain Premarket Submission Reviews: Draft Guidance for Industry and Food and Drug Administration Staff Status / date: Draft, issued October 27, 2025 ² Where to access: https://www.fda.gov/media/189345/download ²

Scope of submissions covered

The draft applies to PMA and HDE applications (it uses "marketing submission" to refer to both), and it expressly reaches PMA supplements, PMA amendments, and HDE supplements ¹²⁶.

What FDA is asking submitters to do

The draft directs submitters to include QMS information tied to the QMSR so FDA can evaluate whether the submission's documents and records conform to QMSR requirements ¹²⁶¹²⁷. Practical instructions include:

Provide a cover letter plus general QMSR information; if the full set of QMSR information is not filed at once, the general information should accompany each submission ¹²⁷.
For an eCopy, include a cover letter carrying the information outlined in the draft's Section V.A.2 ¹²⁷.
For eSTAR PMAs, provide the QMSR information within the eSTAR responses ¹²⁷.
For a modular PMA, submit the QMSR information as a standalone module, separate from other modules ¹²⁷.
Where multiple facilities are involved, identify the activities performed at each facility and provide the applicable QMSR information for each facility in separate, clearly labeled volumes ¹²⁷.

Note: the retrieved pages confirm the structure above but do not reproduce the full Section V.A.2 item-by-item list of specific procedures/records. A reader who needs the exact content checklist should consult Section V of the draft directly.

How it ties to the February 2, 2026 effective date

The draft is written to prepare submitters for the QMSR going live. FDA states that on and after February 2, 2026 it will evaluate marketing-submission documents and records against QMSR requirements, and that device manufacturer inspections assessing CGMP, including PMA preapproval inspections, will evaluate QMSR compliance after that date ¹²⁷¹³⁰. FDA also notes it will update the guidance's references to Part 820 to be consistent with the rule once the rule is in effect ¹³⁰.

What it replaces

When finalized, the draft "will supersede 'Quality System Information for Certain Premarket Application Reviews,' issued February 3, 2003" ¹⁴⁵. That 2003 final guidance (https://www.fda.gov/media/71083/download) had itself replaced the earlier "Guidance for Preparation of PMA Manufacturing Information" and aligned the content recommendations with the then-current QS regulation ¹⁰¹¹⁰³. It applies to PMA, PMA supplement, PDP, HDE, and modular review submissions, and recommends manufacturing/QS information describing the device's methods, facilities, and controls in enough detail for FDA to assess quality control, including production and process controls, acceptance activities, nonconforming product handling, complaint files, and servicing ¹⁰¹¹⁰⁴¹⁰⁸¹¹⁶. The October 2025 draft is the QMSR-era successor to this document.

Comment mechanics

FDA's standard draft-comment instructions apply: comments are due within 60 days of publication of the notice of availability in the Federal Register, and commenters must identify submissions with "the docket number listed in the notice of availability that publishes in the Federal Register" ¹⁴⁵. The specific numeric docket was not present in the retrieved text; confirm it on the Federal Register notice or the guidance's regulations.gov docket page before submitting comments.

Practical takeaways for RA teams

Treat the October 2025 draft as the operative reference for structuring QMS/manufacturing information in PMA and HDE submissions filed into the QMSR era, while recognizing it is still draft and subject to change ²¹²⁷.
Expect FDA review and PMA preapproval inspections to be assessed against the amended Part 820 (ISO 13485:2016) for decisions on or after February 2, 2026 ¹²⁷¹³⁰.
For modular PMAs, plan to carve QMSR information into its own module; for eSTAR PMAs, build it into the eSTAR responses; for multi-site manufacturing, segregate QMSR information by facility ¹²⁷.
If you intend to comment, watch the Federal Register notice of availability for the docket number and the 60-day close ¹⁴⁵.

Open items a reader may want to pursue

The exact Section V.A.2 content checklist (specific procedures, summaries, reports, and lists FDA wants) from the draft.
The numeric Federal Register docket number and the precise comment close date once the notice of availability is located.
Any subsequent finalization of the draft, which would formally retire the 2003 guidance ¹⁴⁵.